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Patent 3170484 Summary

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Claims and Abstract availability

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(12) Patent Application: (11) CA 3170484
(54) English Title: SYSTEM AND METHOD FOR DETERMINING USER INTENTION FROM LIMB OR BODY MOTION OR TRAJECTORY TO CONTROL NEUROMUSCULAR STIMULATION OR PROSTHETIC DEVICE OPERATION
(54) French Title: SYSTEME ET PROCEDE POUR DETERMINER UNE INTENTION D'UTILISATEUR A PARTIR D'UN MOUVEMENT OU D'UNE TRAJECTOIRE D'UN MEMBRE OU DU CORPS POUR COMMANDER UNE STIMULATION NEUROMUSCULAIRE OU UNE OPERATION DE DISPOSITIF PROTHETIQU
Status: Compliant
Bibliographic Data
(51) International Patent Classification (IPC):
  • A61B 5/00 (2006.01)
  • A61B 5/11 (2006.01)
  • A61N 1/04 (2006.01)
(72) Inventors :
  • BOUTON, CHAD EDWARD (United States of America)
(73) Owners :
  • THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH (United States of America)
(71) Applicants :
  • THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH (United States of America)
(74) Agent: MBM INTELLECTUAL PROPERTY AGENCY
(74) Associate agent:
(45) Issued:
(86) PCT Filing Date: 2021-03-05
(87) Open to Public Inspection: 2021-09-10
Availability of licence: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): Yes
(86) PCT Filing Number: PCT/US2021/021232
(87) International Publication Number: WO2021/178914
(85) National Entry: 2022-09-01

(30) Application Priority Data:
Application No. Country/Territory Date
62/985,951 United States of America 2020-03-06

Abstracts

English Abstract

Disclosed is a device for restoring motion to a person's paralyzed body part, for example, the person's hand. The device senses movement of another part of the person's body not affected by the paralysis, for example, the person's arm or shoulder. Motion sensors generate motion signals as the person moves the non-paralyzed body part. A processor stores information associating a predefined trajectory with a particular action, for example, closing the hand to grasp an object. The processor monitors the motion signals and, when the motion corresponds with the predefined trajectory, the processor energizes muscle stimulators connected with muscles that control the paralyzed hand to perform the action, for example, to cause the hand to close around and grasp the object.


French Abstract

Est divulgué, un dispositif permettant de rétablir le mouvement d'une partie corporelle paralysée d'une personne, par exemple, la main d'une personne. Le dispositif détecte le mouvement d'une autre partie du corps de la personne qui n'est pas affectée par la paralysie, par exemple, le bras ou l'épaule de la personne. Des capteurs de mouvement génèrent des signaux de mouvement lorsque la personne déplace la partie corporelle non paralysée. Un processeur stocke des informations associant une trajectoire prédéfinie à une action particulière, par exemple, la fermeture de la main pour saisir un objet. Le processeur surveille les signaux de mouvement et, lorsque le mouvement correspond à la trajectoire prédéfinie, le processeur met sous tension des stimulateurs musculaires connectés à des muscles qui commandent la main paralysée afin d'effectuer l'action, par exemple, pour amener la main à se fermer autour de l'objet et à le saisir.

Claims

Note: Claims are shown in the official language in which they were submitted.


CLAIMS
We claim:
1. A device comprising:
one or more motion sensors, the sensors generating one or more respective
motion signals indicative of movement of a first body part of a human;
a muscle stimulator, wherein the muscle stimulator generates one or more
stimulation signals to cause one or more muscles to displace a second body
part to
perform at least one action; and
a processor connected with the one or more motion sensors and the muscle
stimulator, the processor including data storage, the data storage including
at least
one expected trajectory associated with an intention of the human to perform
the
at least one action, wherein the processor:
receives the one or more signals from the one or more motion sensors;
calculates an actual trajectory of the first body part;
compares the actual trajectory with the expected trajectory; and, based on
the comparison,
actuates the muscle stimulator to displace the second body part to perform
the at least one action.
2. The device of claim 1, wherein the processor computes a difference between
the
actual trajectory and the expected trajectory and actuates the muscle
stimulator based
on the difference.
3. The device of claim 1, wherein the at least one action comprises a
plurality of actions,
wherein the at least one expected trajectory comprises a plurality of expected

trajectories, wherein each of the plurality of expected trajectories is
associated with at
least one of the plurality of actions, wherein the processor compares the
actual
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trajectory with the plurality of expected trajectories to identify a first
trajectory
associated with a fiist action of the pluiality of actions, and wheiein the pi
ocessoi
actuates the muscle stimulator to perform the first action.
4. The device of claim 1, further comprising an input device connected with
the
processor, the input device adapted to a receive a feedback signal, the
feedback signal
indicating that the action was the intended action of the human.
5. The device of claim 1, wherein the processor generates the expected
trajectory based
on a training set of motions.
6. The device of claim 5, wherein the one or more stimulation signals to
perform the at
least one action comprise a pattern of stimulation signals, and wherein the
pattern of
stimulation signals is determined from muscle displacements sensed during the
training set of motions.
7. The device of claim 6, wherein the muscle displacements are sensed using
one or
more of an electromyogram sensor, a camera, an inertial motion unit, a
bend/joint
angle sensor, and a force sensor.
8. The device of claim 1, wherein the processor performs the comparison
using one or
more of a support vector machine (SVM) algorithm, a hand-writing recognition
algorithm, a dynamic time warping algorithm, a deep learning algorithm, a
recursive
neural network, a shallow neural network, convolutional neural network, a
convergent neural network, or a deep neural network.
9. The device of claim 7, wherein the processor performs the comparison using
a Long
Short-Term Memory type recursive neural network.


10. The device of claim 5, wherein the training set of motions are performed
by a second
human.
11. The device of claim 5, wherein the training set of motions are performed
by the
human using a laterally opposite body part of the first body part.
12. The device of claim I, wherein the motion sensor is located on an arm of
the human
and wherein the muscle stimulator is adapted to stimulate muscles to move one
or
more fingers of a hand of the human to perform a grasping motion.
13. The device of claim 1, wherein the expected trajectory is in the shape of
an
alphanumeric character.
14. The device of claim 12, further comprising an orientation sensor connected
with the
processor and adapted to monitor an orientation of the first body part,
wherein a force
applied by the grasping motion depends on an amplitude of the stimulation
signal,
and wherein the processor adjusts an amplitude of the stimulation signal
based, at
least in part, on an output of the orientation sensor.
15. The device of claim 14, wherein the processor adjusts the grasping motion
to be a
key grip, a cylindrical grasp, or a vertical pinch in response to the output
of the
orientation sensor.
16. The device of claim 12, further comprising a camera connected with the
processor
and positioned proximate to the hand to capture an image of an object to be
grasped,
wherein the processor adjusts the grasping motion based in part on the image.
17. The device of claim 12, wherein the processor further comprises a close
delay timer,
wherein the processor delays stimulating the grasping motion for a
predetermined
period at the end of the actual trajectory determined by the close delay
timer.
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18. The device according to claim 12, wherein the processor causes stimulation
of the
hand to perform a post-grasp activity in response to a post-grasp signal from
the
motion sensor.
19. The device of claim 18, wherein the post-grasp activity is opening the
hand to release
the grasp.
20. The device of claim 18, wherein the post-grasp signal is one or more taps
of a
grasped object against a surface.
21. A device comprising:
one or more motion sensors, the sensors generating one or more respective
motion signals indicative of motion of a first body part of a human;
a muscle stimulator, the stimulator generating a stimulation signal adapted
to cause or to increase a contraction of a first muscle, wherein the first
muscle is a
neurologically injured muscle, a paralyzed muscle, a partially paralyzed
muscle,
or a healthy muscle; and
a processor connected with the sensor and the muscle stimulator, the
processor including data storage, the data storage including at least one
expected
trajectory associated with an intention of the human contract the first
muscle,
wherein the processor:
receives the one or more motion signals from the one or more sensors;
calculates an actual trajectory of the first body part;
compares the actual trajectory with the expected trajectory;
determines the intention to contract the first muscle based on the
comparison; and
causes the stimulator to do one or more of:
cause the contraction of the first muscle;
assist the contraction of the first muscle; and
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cause an antagonist contraction of a second muscle, wherein
contraction of the second muscle opposes a movement caused by the
contraction of the first muscle.
22. The device of claim 21, further comprising a nerve stimulator connected
with, and
operable by the processor, wherein, in response to the processor determining
the
intention to contract the first muscle, the nerve stimulator applies a nerve
stimulation
signal to a nerve of the human.
23. The device of claim 22, wherein the nerve of the human is selected from
one or more
of a vagus nerve, a trigeminal nerve, a cranial nerve, a peripheral nerve
feeding the
first muscle, and a spinal cord of the human.
24. The device of claim 23, wherein the nerve is the spinal cord and wherein
the nerve
stimulator comprises a transcutaneous electrode positioned above, over, or
below a
spinal cord injury of the human
25. A device comprising:
one or more motion sensors, the motion sensors generating one or more
respective motion signals indicative of motion of a first body part of a
human;
a prosthetic appendage comprising an actuator adapted to change a
configuration of the prosthetic appendage to perform an action; and
a processor connected with the one or more motion sensors and the
actuator, the processor including data storage, the data storage including at
least
one expected trajectory associated with an intention of the human to perform
the
action, wherein the processor:
receives the one or more motion signals from the one or more motion
sensors;
calculates an actual trajectory of the first body part;
compares the actual trajectory with the expected trajectory and, based on
the comparison,
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actuates the actuator to change the configuration of the prosthetic
appendage to perform the action
26 The device of claim 25, wherein the prosthetic appendage comprises a
prosthetic
hand and wherein the actuator comprises one or more of a wrist actuator and a
finger
actuator.
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Description

Note: Descriptions are shown in the official language in which they were submitted.


WO 2021/178914
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SYSTEM AND METHOD FOR DETERMINING USER INTENTION FROM LIMB OR
BODY MOTION OR TRAJECTORY TO CONTROL NEUROMUSCULAR
STIMUATION OR PROSTHETIC DEVICE OPERATION
BACKGROUND
Field
100011 This disclosure relates to systems, apparatuses, applications, and
methods to assist a
partially disabled person by providing volitional movement of a paralyzed
joint or prosthetic
device by determining the person's intention to move the joint or device from
analysis of limb or
body movements of the person's able-bodied joints. More particularly, this
disclosure relates to
a system, method, or device for determining that the general motion
(translational and/or
rotational motion) or trajectory of a neurologically able limb or other body
part is determinative
of the user's intention to perform an action using a disabled or missing
appendage and, in
response to the determined intention, stimulating the neurologically disabled
part (via the nerve
and/or muscle that controls such part) or a neural target (nerve, spinal cord,
or brain) to promote
neural growth/regeneration or connection strengthening causing recovery of
movement or
function, or to control a prosthetic replacement to perform the action. A
device according to one
embodiment of the disclosure detects the reaching trajectory of a person's
arm, discerns the
person's intention to grasp an object, and activates or modulates a
neuromuscular stimulation
device (NMES) to cause the person's otherwise paralyzed hand (or actuates the
person's
robotic/prosthetic hand) to open and close to grasp and hold the object.
Description of the Related Art
100021 Almost 5.4 million people in the United States alone are living with
paralysis. Stroke and
spinal cord injury are two leading causes. Every year in the U.S. there are
more than 17,700 new
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cases of spinal cord injury (NSCISC, 2019). A majority of these injuries
results in incomplete
(48%) and complete (20%) quadriplegia, which severely affects arm and hand
movements of the
survivors and undermines their quality of life.
100031 A top priority for individuals living with quadriplegia is regaining
hand function. Various
invasive and non-invasive neuromuscular electrical stimulation (NMES) devices
have been
proposed to rehabilitate or evoke upper limb and hand movement. These known
systems have
drawbacks. The Freehand System used shoulder movements coupled to switches
that triggered a
selected hand motion through electrical muscle stimulation via implanted
electrodes. Actuation
of switches may be cumbersome and may require the user to perform unnatural
motions to
operate the muscle stimulator. Such motions may draw attention to the user's
disability and may
impact how the user is perceived by others. Also, the repertoire of hand
motions the user can
perform may be limited by the number of switches that can be operated by a
user's shoulder
muscles.
100041 Other systems may require surgical procedures to implement. For
example, some
systems rely on to implanted el ectromyographi c sensors to detect a patient's
intention to move a
disabled or amputated joint. Cortical brain-computer interfaces (BCIs) have
been used to control
NMES devices by recording and decoding motor activity in the brain to allow
volitional control
of an otherwise paralyzed hand. These approaches require implanting electrodes
or other
structures in the user's body, potentially exposing users to medical risks and
adding significant
cost.
SUMMARY
100051 The present disclosure relates to apparatuses and methods to address
these difficulties.
Patients living with paralysis want to integrate into society without drawing
attention to their
disability as much as possible. While rehabilitation can restore some patients
to at least partial
mobility, it may be difficult or impossible to restore fine motor control, for
example, to allow a
user to reach out and grasp an object like a beverage glass or a piece of
food. The present
disclosure allows patients suffering from the inability to control grasping
motions of their hand
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to perform tasks such as feeding themselves, without having to resort to
tools, such as utensils
affixed to their hand, to perform daily activities.
100061 Patients living with paralysis resulting from a stroke, spinal cord
injury, or other
conditions can lose movement in their hands and/or legs but often can retain
residual movement
in other areas of their bodies. For example, in a CS level spinal cord injury,
the most common
injury level for quadriplegics, movement of the hand is severely impaired, but
shoulder
movement and elbow flexion are spared. Similarly, after a stroke, gross
movement of the arm
(shoulder and elbow) can often be regained through intensive rehabilitation
but regaining hand
movement remains problematic. Finally, a paraplegic or stroke victim may not
have use or full
use of their legs or may suffer from foot drop (lacking ankle flexion
ability), but may have arm
movement or trunk or hip movements they can still make.
100071 Disclosed herein are methods and systems that return volitional control
of the user's
paralyzed joints and/or external devices by sensing and recognizing the
movement and
trajectories in able-bodied joints the person still possesses. The system
discerns the intention of
the user to perform an action using the paralyzed or prosthetically replaced
joint using
computerized algorithms including machine learning that adapt to the user's
particular body
motions. The detected body motions and trajectories can then be used to drive
a wide variety of
desired outcomes. According to one embodiment, such a system determines a
person's intention
to reach out to grasp an object and actuates an NMES device to open and close
the user's
paralyzed hand to grasp and hold the object.
100081 The present disclosure includes devices that sense and recognize limb
trajectories (e.g.,
reaching motions controlled by residual shoulder and elbow movements) and
other body
motions, positions, or orientations to activate muscles of a disabled body
part through electrical
stimulation via electrodes or electrode arrays, to cause a specific activity,
for example, a "key
grasp" pinching motion of the hand, and the like, or energize actuators on a
prosthetic body part.
A variety of predefined trajectories and limb or body motions, which could be
a combination of
translational and rotational type motions, may be stored, each trajectory or
motion associated
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with a different action. Based on recognized motions, a device according to
embodiments of the
disclosure can also be used to control of external devices, for example, a
computer or motorized
wheelchair. Moreover, many distinct trajectories can be identified with
different actions,
allowing the repertoire of actions available to the user to expand.
100091 The present disclosure also includes devices that recognize motion
about able-bodied
joints such as the hip, lumbar spine, and knee to identify motions associates
with a person's gait
and apply stimulation signals to muscles in synchrony with the person's gait.
Such a device may
be used to restore a more effective gait motion where neurological injury has
impaired motion of
the person's foot, ankle, or leg. Such a device may be used to strengthen
muscles required for
walking preoperatively, for example, before a hip or knee replacement
procedure, and/or post-
operatively as part rehabilitation treatment.
100101 According to another embodiment, instead of, or in addition to
energizing electrodes or
prosthetic devices to enable movement, a system according to the disclosure
delivers electrical
stimulation to the site of the neurological injury, or a neural pathway
connected to the
neurological injury (e.g. spinal cord, brain, or peripheral nerve). By
providing electrical
stimulation, with electrodes being placed transcutaneously or epidurally, over
or near to the site
of a spinal cold, nerve, or brain injury, while at the same time moving the
affected limb, a system
according to the disclosure may assist in repair of injured motor fibers,
nerves or neurons. The
system may also provide electrical stimulation, with electrodes being placed
transcutaneously or
epidurally, over or near or superior to the site of the injury, in the case of
spinal cord injury, to
potentially assist in the healing of damage to sensory fibers, nerves or
neurons.
100111 Using sensors on the arms, legs, and/or body, a wide variety of two-
and three-
dimensional (2D/3 D) motions (translational acceleration, rotational velocity,
and orientation with
respect to earth's magnetic field) can be recognized. According to some
embodiments, such
motion is detected by inertial motion units (IMUs) that have 3 to 9 degrees-of-
freedom in total.
According to other embodiments, visual images of motions may be recognized as
well Just as a
child traces letters, numbers, and patterns in the air with a sparkler, the
device recognizes fluid,
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natural curvilinear arm reaching trajectories and pre-trained patterns such as
well-known script
numbers and letters. The user can then perform motions of their choice or
natural leaching
trajectories, and these motions are recognized and, in turn, used to control
various neuromuscular
stimulation and prosthetic/robotic devices that facilitate movement in the
paralyzed joints. In the
arm, movement trajectories of the arm, driven by residual shoulder movements,
can be used to
drive stimulation or robotic control of multiple wrist, hand, and finger
movements (or external
devices such as a computer, stereo, etc.).
100121 In addition to enabling patients to grasp objects using residual
mobility, a device
according to embodiments of the disclosure may improve neurological function
by providing
feedback to the patient's central nervous system to associate motions of able
joints and limbs
with activation of the disabled body part. Thus, using such a device to drive
neuromuscular or
robotic-driven movement in paralyzed joints, has assistive, rehabilitative,
and therapeutic
applications in stroke, spinal cord injury, and other neurodegenerative
conditions. This approach
also has application in general physical therapy after injury or surgery to
the hand, foot, leg, or
other parts of the body.
100131 Furthermore, the disclosed embodiments can be used to measure, track,
and recognize
(through machine learning algolithms such as those disclosed) the quality of
limb/body
movement trajectories over time in rehabilitative applications. Because motion
of j oints is
captured, recorded, and recognized or graded, a physical therapist can monitor
a patient's
progress and tailor the therapy to address particular parts of body motion
that may be
problematic. Machine learning or other forms of artificial intelligence,
including deep learning
methods, can be used to analyze aggregate data (from many anonymous patients)
to find general
patterns and metrics indicating progress or setbacks and issues that can be
flagged for review or
corrective action.
100141 According to one embodiment a device is disclosed comprising one or
more motion
sensors, the sensors generating one or more respective motion signals
indicative of movement of
a first body part of a human, a muscle stimulator, wherein the muscle
stimulator generates one or
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more stimulation signals to cause one or more muscles to displace a second
body part to perform
at least one action, and a processor connected with the one of more motion
sensors and the
muscle stimulator. The processor includes data storage, the data storage
including at least one
expected trajectory associated with an intention of the human to perform the
at least one action.
The processor receives the one or more signals from the one or more motion
sensors, calculates
an actual trajectory of the first body part, compares the actual trajectory
with the expected
trajectory, and, based on the comparison, actuates the muscle stimulator to
displace the second
body part to perform the at least one action. The processor may compute a
difference between
the actual trajectory and the expected trajectory and perform the comparison
and actuate the
muscle stimulator based on the difference.
100151 According to one embodiment the at least one action comprises a
plurality of actions and
the at least one expected trajectory comprises a plurality of expected
trajectories. Each of the
plurality of expected trajectories is associated with at least one of the
plurality of actions. The
processor compares the actual trajectory with the plurality of expected
trajectories to identify a
first trajectory associated with a first action of the plurality of actions,
and processor actuates the
muscle stimulator to perform the first action. The device may comprise an
input device
connected with the processor where the input device adapted to a receive a
feedback signal. The
feedback signal may indicate that the action was the intended action of the
human. The
processor may generate the expected trajectory based on a training set of
motions. The one or
more stimulation signals to perform the at least one action may comprise a
pattern of stimulation
signals, and the pattern of stimulation signals may be determined from muscle
displacements
sensed during the training set of motions. The muscle displacements may be
sensed using one or
more of an electromyogram sensor, a camera, an inertial motion unit, a
bend/joint angle sensor,
and a force sensor. The processor may perform the comparison using one or more
of a support
vector machine (SVM) algorithm, a hand-writing recognition algorithm, a
dynamic time warping
algorithm, a deep learning algorithm, a recursive neural network, a shallow
neural network,
convolutional neural network, a convergent neural network, or a deep neural
network. The
processor may perform the comparison using a Long Short-Term Memory type
recursive neural
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network. The training set of motions may be performed by a second human. The
training set of
motions may be performed by the human using a laterally opposite body part of
the first body
part. The motion sensor may be located on an arm of the human and the muscle
stimulator may
be adapted to stimulate muscles to move one or more fingers of a hand of the
human to perform
a grasping motion. The expected trajectory may be in the shape of an
alphanumeric character.
100161 According to one embodiment the device comprises an orientation sensor
connected with
the processor and adapted to monitor an orientation of the first body part A
force applied by the
grasping motion may depend on an amplitude of the stimulation signal and the
processor may
adjust an amplitude of the stimulation signal based, at least in part, on an
output of the
orientation sensor. The processor may adjust the grasping motion to be a key
grip, a cylindrical
grasp, or a vertical pinch in response to the output of the orientation
sensor. The device may
comprise a camera connected with the processor and positioned proximate to the
hand to capture
an image of an object to be grasped. The processor may adjust the grasping
motion based in part
on the image. The processor may comprise a close delay timer and the processor
may delay
stimulating the grasping motion for a predetermined period at the end of the
actual trajectory
determined by the close delay timer. The processor may cause stimulation of
the hand to
perform a post-grasp activity in response to a post-grasp signal from the
motion sensor. The
post-grasp activity may be opening the hand to release the grasp. The post-
grasp signal may be
one or more taps of a grasped object against a surface.
100171 According to another embodiment a device is disclosed comprising one or
more motion
sensors, the sensors generating one or more respective motion signals
indicative of motion of a
first body part of a human, a muscle stimulator, the stimulator generating a
stimulation signal
adapted to cause or to increase a contraction of a first muscle, wherein the
first muscle is a
neurologically injured muscle, a paralyzed muscle, a partially paralyzed
muscle, or a healthy
muscle, and a processor connected with the sensor and the muscle stimulator.
The processor
includes data storage, the data storage including at least one expected
trajectory associated with
an intention of the human contract the muscle. The processor receives the one
or more motion
signals from the one or more sensors, calculates an actual trajectory of the
first body part,
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compares the actual trajectory with the expected trajectory, determines the
intention to contract
the muscle based on the comparison, and causes the stimulator to do one or
more of cause the
contraction of the first muscle, assist the contraction of the first muscle,
and cause an antagonist
contraction of a second muscle, where contraction of the second muscle opposes
a movement
caused by the contraction of the first muscle. The device may comprise a nerve
stimulator
connected with, and operable by the processor and in response the processor
determining the
intention to contract the first muscle, the nerve stimulator may apply a nerve
stimulation signal to
a nerve of the human. The nerve of the human may be selected from one or more
of a vagus
nerve, a trigeminal nerve, a cranial nerve, a peripheral nerve feeding the
first muscle, and a
spinal cord of the human. The nerve may be the spinal cord and the nerve
stimulator may
comprise a transcutaneous electrode positioned above, over, or below a spinal
cord injury of the
human.
100181 According to one embodiment a device is disclosed comprising one or
more motion
sensors, the motion sensors generating one or more respective motion signals
indicative of
motion of a first body part of a human, a prosthetic appendage comprising an
actuator adapted to
change a configuration of the prosthetic appendage to perform an action, and a
processor
connected with the one or more motion sensors and the actuator. The processor
includes data
storage, the data storage including at least one expected trajectory
associated with an intention of
the human to perform the action. The processor receives the one or more motion
signals from
the one or more motion sensors, calculates an actual trajectory of the first
body part, compares
the actual trajectory with the expected trajectory and, based on the
comparison, actuates the
actuator to change the configuration of the prosthetic appendage to perform
the action. The
prosthetic appendage may comprise a prosthetic hand and the actuator may
comprise one or
more of a wrist actuator and a finger actuator.
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BRIEF DESCRIPTION OF THE DRAWINGS
10019] A more complete appreciation of the disclosure and many of the
attendant advantages
thereof will be readily obtained as the same becomes better understood by
reference to the
following detailed description when considered in connection with the
accompanying drawings,
wherein:
100201 Fig. 1 shows a person's arm and hand equipped with a device according
to an
embodiment of the disclosure performing a test to measure finger dexterity;
100211 Fig. 2 is a block diagram of a system according to one embodiment of
the disclosure;
100221 Fig. 3 shows the position, velocity, and acceleration of the person's
arm equipped with
the device as shown in Fig. 1 when the person moves his arm along a "C"-shaped
path of
motion;
100231 Fig. 4 shows the position, velocity, and acceleration of the person's
wrist equipped with
the device as shown in Fig. 1 when the person moves his arm along a "number 3"-
shaped path of
motion;
100241 Fig. 5, shows a system according to embodiments of the disclosure
integrated into a
wearable patch;
100251 Fig. 6 shows a person's arm and hand equipped with a device according
to an
embodiment of the disclosure transferring a pen from one location to another;
100261 Fig. 7 is a graph showing the performance of apparatus according to
embodiments of the
disclosure in identifying a patient's limb motion with a predefined
trajectory;
100271 Fig. 8 shows a comparison of confusion matrices for embodiments of the
present
disclosure using different machine learning algorithms to identify predefined
trajectories; and
100281 Fig. 9 shows a prosthetic limb including a device according to an
embodiment of the
disclosure.
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DETAILED DESCRIPTION
100291 Some patients who have suffered neurological injury, such as a stroke
or spinal cord
injury have lost the ability to control motion in one part of their body but
retain the ability to
move other body parts. In some cases, the residual limb motion may allow the
patient to move
their shoulder and upper arm and to flex their elbow while the ability to
control the motion of the
hand, for example, to grasp an object, is lost. In other cases, a patient may
have lost the ability to
articulate their knee and ankle, while they retain residual motion of their
hip. In the case of
amputees, a patient may retain complete function of the residual portion of
the amputated limb.
100301 A system according to embodiments of the present disclosure senses and
recognizes -
through machine learning methods - residual limb trajectories and body motions
in space and
discerns the intention of the user to perform a specific action. Using sensors
on the arms, legs,
and/or body, a wide variety of two- and three-dimensional (2D/3D) motions,
including
translational, rotational or combinations thereof, can be recognized. The
system includes
circuitry that delivers NMES signals to muscles controlling motion of the
disabled body part or
operates a robotic/prosthetic limb to restore hand/arm or foot/leg control.
100311 According to a further embodiment, the system detects the fluid,
natural, curvilinear path
of motion of the functional body part normally associated with a desired
action and causes the
disabled body part to execute the action. For example, in a patient that has
residual motion in his
or her shoulder and upper arm, the device recognizes reaching trajectories and
causes the
patient's disabled hand to open and close to grasp an object. As used herein,
the term
"trajectory" means general motion of a body part including translational
and/or rotational motion
of the body part in space, as well as angular displacement of the body part
about a joint (e.g.
deflection of the elbow, shoulder, hip or knee).
100321 Different reaching trajectories can be detected and, in response the
system positions the
patient's hand appropriately for that type of reach. For example, where the
patient moves their
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arm and shoulder forward, or in a curvilinear pathway, with the wrist in the
neutral, "hand-
shake" position, the system discerns that they intend to grasp a vertically
oriented object like a
glass or water bottle resting on a tabletop (a "cylindrical grip") by
comparing the actual
trajectory of the arm or shoulder with an expected trajectory associated with
patients intent. In
response to the discerned intention, the system energizes NMES electrodes on
the patient's
forearm to activate the appropriate muscles to cause the hand to open in
preparation of grasping
the object and then, after a delay, the system stimulates muscles causing the
fingers to wrap
around the object and hold it securely. Alternatively, where the patient uses
the residual motion
of their shoulder and arm to reach along a vertical "rainbow" arc, the system
discerns that the
user intends to pick up an object from above with a pinching hand motion (a
"vertical pinch").
Also, a patient may reach for an object using a "corkscrew" motion to indicate
their intention to
perform a third type grasp, such as a "claw grasp" to pick up an object. The
device actuates
NN4ES electrodes controlling the hand to cause the patients thumb and fingers
to open and then
come together around the top of the object. An advantage of using natural
motions of the
residual body part to control the disabled body part is that the patient's
actions more closely
match an able-bodied person. This can draw less attention to the user and may
promote
neuroplasticity and rehabilitation in a stroke patient or recent spinal cord
injury patient, for
example.
[0033] The types of residual motion detected can also include predetermined
trajectories that the
patient executes, for example, movement of the arm along a -C"-shaped path.
Just as a child
traces letters, numbers, and patterns in the air with a sparkler, the device
recognizes the pattern.
The patient moves his able-bodied joint along the predetermined expected
trajectory and the
system discerns that a particular action is intended. In response, the system
actuates NMES
electrodes that cause muscle contractions to execute the desired action. For
example, a patient
might execute a "C"-shaped motion with the shoulder and upper arm to cause the
hand to open
and close around a cylindrical object and an "S"-shaped motion to close the
hand in a pinching
motion. An advantage of using pre-programmed expected trajectories is that the
number of
specific motions that can be encoded is vast. The device can be programmed to
recognize both
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pre-trained patterns and natural reaching trajectories. Moreover, new
trajectories for new actions
can be added to the patient's repertoire of actions.
100341 According to one embodiment, the device energizes NMES electrodes to
stimulate the
proper muscle contractions to execute the intended action. According to other
embodiments the
device recognizes motion paths of the patient's able body part to actuate
prosthetic/robotic
devices that facilitate movement in the paralyzed joints. In the arm, movement
trajectories of the
arm, driven by residual shoulder movements, can be used to drive stimulation
or robotic control
of a prosthetic hand adapted to perform multiple wrist, hand, and finger
movements. Such a
prosthetic hand includes a combination of wrist and finger actuators. In
addition, certain motions
can be detected to control external devices such as a computer, stereo, a
motorized wheelchair,
and the like. Because the number of distinct motion paths is quite large, the
device can be used
both to control a disabled body part, for example, using the natural
trajectory of the shoulder in a
reaching motion to control a disabled hand, and to control an external device
like a computer
using a pre-programmed motion path, (e.g., a "C"-shaped path).
100351 Using devices according to embodiments of the disclosure to drive
neuromuscular or
robotic-driven movement in paralyzed joints may have additional assistive,
rehabilitative, and
therapeutic applications in stroke, spinal cord injury, and neurodegenerative
conditions. Because
the patient uses residual motion in the able-body joints, the patient
strengthens the musculature
and neural connections to perform that residual motion. In addition, as the
device is used, brain
plasticity associates the residual motion (both natural motions and pre-
programmed motion
paths) with the desired action, making the patient's motions appear more fluid
like that of an
able-bodied person. This approach also has application in general physical
therapy after injury
or surgery to the hand, foot, or other parts of the body. Furthermore, the
disclosure herein can be
used to measure and track the quality of limb/body movement trajectories over
time in
rehabilitative applications.
100361 Fig. 1 shows the hand and forearm of a patient equipped with a device
according to an
embodiment of the disclosure while preforming a "Nine-hole Peg Test," a
standard measure of
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hand dexterity known to those of skill in the art. At the top of the patient's
wrist is a wearable
sensor housing 10 that includes motion sensors to detect the path of motion of
the patient's hand
and orientation of the patient's limb. As will be explained more fully below,
the sensors may
include inertial motion units (IMUs) to detect three-axis acceleration,
gyroscopic sensors to
detect rotational velocity, and magnetic sensors to detect orientation in
earth's magnetic field.
According to other embodiments, sensors can also include joint angle/bend
sensors to detect
flexing of a joint such as the elbow, knee, or hip. A computer (or
microprocessor embedded in
the device), not visible in Fig. 1, is in communication with the IMU. The
computer includes a
processor, memory, and/output devices. According to the embodiment shown in
Fig. 1, the IMU
communicates with the computer via a radio frequency Bluetooth link. NMES
electrodes 12 are
in contact with the patient's abductor pollicis brevis and flexor pollicis
brevis in this test to
govern basic movement of the thumb.
100371 Fig. 2 is a block diagram illustrating an embodiment of the system in
Fig. 1. Sensor
housing 10 includes sensors 16a, 16b, ...16n. These may include IMUs, joint
bend/angle
sensors, cameras, gyroscopic sensors, force sensors, as well as other sensors
for monitoring
motion and orientation. A microcontroller 18 is connected with the sensors to
preprocess
signals from the sensors to integrate outputs from various sensors to provide
trajectory data such
as body part orientation, 3-axis linear acceleration corrected for gravity, or
general motion
(translational and/or rotational) information. Output from microcontroller 18
is provided to
computer system 20 to provide signals indicating the path of motion of the
patient's hand and
analyze that motion, as will be described below. According to one embodiment,
microcontroller
18 and computer 20 include radio frequency transceivers 19a and 19b, such as a
Bluetooth or
ZigBee protocol devices to communicate motion data wirelessly. According to
other
embodiments, the functions of computer 20 may be integrated into the
microcontroller 18. This
microprocessor can also be a neural processor or neural processing unit or
tensor processor
optimized for machine learning or deep learning consuming low levels of power,
making it ideal
for wearable devices (examples include the M1 processor by Apple (Cupertino,
CA) or Cortex-
M55 by Arm (Cambridge, England). Computer 20 may also include a network of
computers
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connected locally and/or computer systems remote from the wearer, such as
cloud computing
systems.
100381 According to the embodiment shown in Fig. 1, sensor housing 10 is worn
like a
wristwatch. Other types of housing could also be used. For example, the sensor
housing 10
could be built into a cuff, sleeve, or wearable adhesive patch (with
electrodes, microprocessor or
artificial neural network or AT processor, visual indicators such as LEDs,
wireless
communication, and disposable conductive adhesive material) on the patient's
forearm, or a
glove worn over the patient's hand. Such a sleeve or wearable adhesive patch
may incorporate a
joint bend/angle sensor to detect flexing of the patient's elbow. For
applications where residual
motion of other body parts controls actuation of a disabled limb or external
device, the device
could be worn as a belt (to detect hip motion), as part of a hat or headband
(to detect motion and
orientation of the patient's head), or built into an article of clothing worn
elsewhere on the
patient's body.
100391 Computer 20 is connected with an NMES driver 14 that generates currents
to apply to a
plurality of NN4ES electrodes 12a, 12b, 12c, ...12n. The NMES electrodes are
placed on the
patient's forearm or are incorporated into a cuff, sleeve, or adhesive patch.
According to one
embodiment, NMES electrodes 12a, 12b, 12c, ...12n are arranged in a sleeve
that fits securely
onto the patient's forearm as shown in Fig, 5 and discussed in detail below.
The arrangement of
electrodes is selected to correspond with the muscular anatomy of the forearm.
Once in place,
the NMES electrodes may be mapped to the patient's musculature.
100401 NMES driver 14 generates stimulation waveforms that are applied to
selected sets of
electrodes. Parameters for the waveform, including waveform shape (square,
sinusoidal,
triangular, or other), pulse-width, pulse frequency, voltage, and duty cycle,
are selected and the
NMES driver is set to apply these signals in response to control signals from
computer 20.
According to one embodiment, stimulation is applied as a series of brief
bursts separated by an
inter-burst period. NMES parameters may be selected to improve penetration
through the skin,
to more precisely isolate finger and thumb movements, and to reduce fatigue.
The electrodes are
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mapped to specific muscles in the patient's forearm so that the stimulation
signals from the
NMES driver activate selected muscles to activate fingers and thumb flexion
and extension.
100411 In the example shown in Fig. 1, NMES electrodes are applied to the
patient's forearm
using adhesive tape or an adhesive conductive material or hydrogel.
Alternatively, electrodes
could be built into a patch (with disposable adhesive hydrogel) or cuff with
integrated sensors
and microprocessor or AT processing unit worn over the patient's forearm as
shown in Fig. 5 and
discussed below. Other methods of connecting and orienting electrodes relative
to the patient's
musculature know to those of skill in the art may be used. In the embodiment
shown in Fig. 1,
electrodes 12a, 12b, 12c, ... 12n are arranged to apply a stimulation current
to one or more of the
thumb muscles controlling the thumb (the abductor pollicis brevis, flexor
pollicis brevis, and
opponens pollicis), which evoke various useful thumb movements including
"pinching" (with tip
of index) and "key" style grasping.
100421 Computer 20 includes hardware and software components for receiving
signals from
sensors 16a, 16b, ...16n to determine the trajectory and orientation of
housing 10, and hence, the
path of motion and orientation of the patient's limb. Based on this, computer
20 sends signals to
the NMES driver 14 to energize electrodes 12a, 12b, 12c, ...12n according to a
sequence that
causes the patient's hand to assume the intended configuration. According to
one embodiment,
computer 20 also provides output to an output device 22 such as a display
monitor or screen and
receives input from one or more input devices 24, such as a keyboard, a
computer mouse or other
pointing device, and/or a microphone. Output from the computer may also be
recorded and used
by medical professionals to assess the patient's progress during physical
therapy. In addition, as
will be discussed more fully below, the output may be anonymized and
collected, along with
similar data from a population of patients and used to train machine learning
systems to better
recognize body motions and trajectories that indicate the intention of a user
to perform the
intended action.
100431 According to another embodiment, computer 20, NMES driver 14,
microcontroller 18,
and the array of NMES electrodes 12a, 12b, 12c, ...12n are integrated with the
sensor housing 10
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to form a portable, wearable system. Such a wearable system might include a
touchscreen or
other input/output device similar to a "smart watch" to allow the patient to
interact with the
system, for example, to train the system to better discern the patient's
intentions. Connections
between computer 20 and other components of the system may be a physical
connection, e.g.,
cables. Alternatively, computer 20 may communicate signals wirelessly by a
radio frequency
link (e.g., Bluetooth, ZigBee) or via infrared. The computer 20 includes
memory storage and is
programmed to perform various algorithms, as will be described more fully
below. According to
other embodiments, computer 20 is also integrated into sensor housing 10. Such
an embodiment
provides a self-contained system allowing the wearable system to be used
independently from
any wired or wireless interface.
100441 Fig. 5 shows an embodiment of the disclosure with an array of NMES
electrodes 12a,
12b, ...12n integrated on a wearable patch 15. An electrical coupling layer
13, such as a
hydrogel layer is provided between the electrode array and the wearer's skin.
In the embodiment
shown in Fig. 5, electrodes 12a, 12b, ...12n are arranged in a pattern
adjacent to the musculature
controlling the wearer's hand. According to one embodiment, other components,
such as sensor
housing 10 including IMU sensors 16a, 16b, ...16n, microcontroller 18, NIMES
driver 14,
computer 20, and a power source are also disposed on wearable patch 15. This
embodiment
eliminates cabling, allowing the user to freely move the able-bodied joint, in
this case the
shoulder, torso, and upper arm, or hip, to actuate the system to stimulate
intended actions in the
disabled joints of the hand, lower leg, or foot. Eliminating cabling enables
the device to be worn
continuously to assist the user with daily activities. Electrode array 12 may
be programmed to
map particular NMES drivers 12a, 12b, ...12n to the wearer's musculature so
that energizing
specific electrodes or sets of electrodes results in particular motions, for
example, grasping
motions, as described above, or lower leg, or foot. Such mapping may use
machine learning
techniques to fine tune the activation of muscles to the intentions of the
wearer.
100451 In the example shown in Fig. 1, inertial sensors (IMUs) 16a, 16b, ...
16n in housing 10 on
the patient's wrist sense 2D and 3D arm trajectories and send signals to
computer 20. These
signals are analyzed and compared with one or more expected trajectories
associated with a
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desired action using data fitting and/or machine learning algorithms running
on computer 20.
When a trajectory or motion indicating that the patient intends to perfor-m a
particular action is
recognized, computer 20 sends signals to the NMES driver 14 to activate
selected electrodes 12a,
12b, 12c, ...12n to control neuromuscular stimulation patterns in the forearm
to control the hand
to "open" and "close."
100461 The IMUs monitor the actual trajectories of the patient's limbs and
provide signals that
are analyzed to indicate desire movements or device actions. The IMUs may
detect 6-axis
(acceleration and rotational velocity) or 9-axis (adding magnetic field
information) motion. One
or more housings with IMUs can be placed on various limb, body, or head
locations and used to
provide orientation and translation information for the patient's limb
segments in the leg, hand,
foot, hip, neck, head, or any other body part.
100471 When the patient shown in Fig. 1 moves his hand in a vertical -rainbow"
arc, output of
the IMU attached to his wrist (or forearm) is analyzed by computer 20 to
detect this as an
expected trajectory and discern that he intends to grasp a peg from the
pegboard using a "key
grip" type motion. As the patient's hand nears the end of the vertical arc
trajectory, computer 20
causes NMES driver 14 to stimulate the patient's muscles to curl the fingers
of the hand and to
move the thumb away from the index finger so that the thumb is extended and
prepared to
assume a -key grip" on the peg. When the hand reaches the end of the vertical
arc trajectory,
computer 20 causes the thumb to remain spaced away from the side of the index
finger for a time
delay to allow the patient to position the hand with respect to the peg using
his residual shoulder
and arm function. At the end of the delay, computer 20 actuates the NEMS
electrodes over the
extensor pollicis brevis muscle thus closing the grip on the peg. NEMS signals
remain active so
that the peg remains securely gripped. Other general motions (i.e.,
translational and/or rotational
motions) of the patient's wrist or forearm could be sensed to determine the
patient's intention to
perform other types of grasping motions. For example, the patient may reach
for an object using
a "corkscrew" motion to indicate their intention to perform another type of
grasp, such as a
"claw grasp" to pick up an object.
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100481 Computer 20 keeps the muscles activated until the patient performs
another motion or
trajectory indicating that the patient wishes to release his grip. According
to one embodiment,
when the patient moves their hand (using residual shoulder/elbow movement) in
a small
clockwise or counter-clockwise motion in the horizontal plane parallel to the
table's surface the
motion is detected by an accelerometer, for example, one or more of the EVIU
sensors 16a, 16b,
...16n. This motion is interpreted by computer 20 as indicating the patient's
intent to release the
peg. The computer 20 causes NMES currents to be applied to move the thumb away
from the
forefinger, opening the grip and releasing the peg. Other motions could be
used to indicate that
the object should be released, such as a pronation or supination (rotation)
type motion of the
forearm. The user may select any pattern of motion or body movement to
indicate the intent to
release the grip, which can be identified to the pattern recognition and/or
machine learning
algorithms to evoke a "hand open" neuromuscular stimulation pattern. According
to another
embodiment, instead of, or in addition to, a body motion or trajectory, the
signal that the patient
intends to release the object is an abrupt signal, such as tapping the object
on a surface one or
more times, thereby generating an accelerometer signature signal. A tapping
signal may be
particularly advantageous when a cylindrical object such as a water glass is
grasped because
tapping can be done subtly, so as not to draw attention to the person's
disability. A simple
clockwise or counterclockwise circular motion in the horizontal plane can also
be used to
indicate the user desires to open their hand and release the object.
100491 According to another embodiment, instead of sending signals to an NMES
driver,
computer 20 is connected with motorized actuators of a robotic/prosthetic hand
that replaces a
patient's amputated hand. In this embodiment, the robotic hand is controlled
to perform grasping
actions in response to the detected arm trajectory.
100501 According to one embodiment, the interpretation of a trajectory depends
on the state of
the system prior to detecting the trajectory. In the example just given, in
the state where an
object has been grasped, the clockwise circular motion/trajectory in the
horizontal plane is
interpreted as a command to release the object. When the system is in a
different initial state, for
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example, when the hand is in an "open" position, a clockwise circular motion
might cause a
different action, for example, to perform a claw grasp.
100511 Embodiments of the disclosure are not limited to detecting motion of
the hand or arm.
The human body can achieve an infinite number of motions in space as we move
our limbs and
trunks in various patterns. Specifically, the rotation and trajectory in space
of our arms and legs,
and even hips and trunk, contain a vast amount of information. Disclosed here
are methods and
devices to sense and recognize a variety of movements to achieve various
desired outcomes in a
robust accurate way. Natural reaching movements (using residual shoulder
movement) can be
described by specific straight or curved motions in space, sometimes
accompanied by limb (or
body) rotation as well. For example, with this approach a quadriplegic user
can move their arm
along a curved path towards an object and this trajectory will be
automatically recognized and
subsequently trigger neuromuscular stimulation causing their hand to open and
then close (after a
short delay) around an object.
100521 An 1MU can also provide orientation information which can be very
useful. If, for
example, the IMU is located on the back of the wrist (forearm side of the
wrist where a watch
face would be located), and the hand is in a neutral (handshake) position,
this information,
combined with a specific reaching trajectory can indicate the user desires to
grasp a cylindrical
object such as water bottle or glass. 2D arm trajectory and/or orientation
patterns can be used to
drive a large number of actions including device control and muscle
stimulation patterns for
various hand/leg movements. Furthermore, various trajectories can be used to
control different
types of grasping. As discussed above, a rainbow-like arc trajectory, as a
user reaches out and
over the top of an object lying on a table, could trigger a claw type open and
close grasp for
picking up that object from above. A clockwise-corkscrew type reaching
trajectory could be used
to control a cylindrical grasp, while a counter-clockwise corkscrew reaching
pattern could be
used for a pinch-type grasp.
100531 In addition to IMUs, other sensors can be used to detect motion of able-
bodied joints.
According to one embodiment, a bend sensor is provided at the elbow to provide
additional
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input. This input can be used to further identify a particular trajectory.
Elbow bending may also
be used to modulate the neuromuscular stimulation current amplitude for
driving grasp strength
during gripping actions (or the closing force of a robotic end effector).
100541 According to another embodiment of the disclosure, instead of, or in
addition to detecting
natural body motions, the device detects one or more predefined trajectories.
Just as one moves
a sparkler in the air, recognizable patterns and shapes can be generated
(e.g., letters, numbers,
corkscrew/spiral, etc.). Sensors 16a, 16b, ...16n detect motions associated
with such patterns
and computer 20 analyses the signals form the sensors to determine if the
patient has executed a
pattern that corresponds to a particular action. The user can select any
patterns they prefer and
link it to various movements or device actions (home electronics, computer,
mobile device,
robotic arm, wheelchair, etc.). These trajectories can be used to interact
with, control, or drive
these devices under direct user control.
100551 A device was constructed according to embodiments of the disclosure.
Sensors 16a, 16b,
... 16n consisted of a Bosch SensorTec BN0055 9-axis IMU. The sensor was
connected with a
microcontroller 18, here a 32-bit ARM microcontroller unit (MCU) from Adafruit
(Feather
Huzzah32). The IN/IU has a built-in processor and algorithms to estimate its
orientation and
perform gravity compensation in real-time to produce linear acceleration in
three orthogonal
directions. Linear acceleration along the X, Y, and Z axes was available
externally via an I2C
interface. A flexible printed circuit board was designed to interconnect the
IMU with the MCU
18. Data was continuously streamed from the MCU at 50Hz via Bluetooth to a
computer 20.
Computer 20 used MATLAB 2019a to store and process motion data for embodiments
where
processing was performed offline.
100561 In other embodiments, MCU 18 performed data processing in real-time to
actuate muscle
stimulators positioned on a test subject's forearm. Neuromuscular stimulation
was provided by a
battery-operated, 8-channel, voltage-controlled stimulator, with a stimulation
pulse frequency of
20Hz. The stimulation channels were mapped to individual or multiple
electrodes on a fabric
sleeve, in order to evoke various finger flexion and extension type movements.
By grouping
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multiple stimulation channels and sequencing their activation profile,
different grasp types such
as cylindrical and pinch grasps were programmed.
100571 Fig. 3 shows motions recorded by a device according to a further
embodiment of the
disclosure. In this example, an able-bodied person wearing a device according
to an embodiment
of the disclosure moved his arm along a "C"-shaped trajectory. In this
example, the person
repeated the motion three times. Signals from IMU provided 6-axis data
(acceleration and
rotational velocity) of the persons wrist. The output of the IMU is corrected
for gravity to
provide repeatable acceleration data that is integrated to determine the time-
dependent position
(i.e., the trajectory) of the limb during the motion. Based on the trajectory,
computer 20
determined that the "C"-shape trajectory was made. In each repetition, the "C"-
shape is apparent
in the X/Y position displayed in the right-most column of graphs.
100581 Computer 20 may use pattern recognition algorithms to analyze and
identify limb and
body motions and trajectories to discern the patient's intention to perform an
action. The
analysis may include signal processing algorithms including Dynamic Time
Warping (DTW) to
compare the actual trajectory of a patient's limb motion with the trajectory
expected to
correspond to an intentional action DTW has the advantage of being able to
accommodate
different motion/trajectory speeds or timing profiles that different users may
have.
100591 According to other embodiments machine learning techniques are applied
to analyze the
sensor output to discern the user's intention to perform a certain action and
to distinguish other
motions where the user does not intend an action to occur. According to one
such embodiment,
computer 20 includes a convolutional neural network (CNN) or recurrent neural
network (RNN)
to analyze data from IMUs and other sensors to identify body motions and
trajectories that signal
the patients intention to perform an action or camera data to provide
additional contextual
information to further discern the user's intentions or information about the
object the hand is
approaching (shape and size of the object the hand must accommodate and
grasp). The RNN
implements techniques such as Long Short-Term Memory (LSTM) to identify
volition-signaling
motions. Using such techniques, the system repeatedly and reliably identifies
specific
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trajectories or body motions and actuates the patient's muscles or motorized
prosthetic devices to
perform the intended action. In addition, because sensor data is recorded,
systems according to
the disclosed embodiments can be continually trained to better identify the
patient's intentions.
Data from multiple patients, when properly anonymized, may be gathered and
used to train the
machine learning algorithm. Various other machine learning algorithms can be
used to analyze
and identify natural and pre-programmed trajectories. These include but are
not limited to,
support vector machine (SVM) algorithms, hand-writing recognitions algorithms,
and deep
learning algorithms. Such machine learning algorithms may be implemented
locally on a
computer 20 worn on the patient's person (e.g., built into to a prosthesis or
connected with the
sensor housing 10). Alternatively, or in addition to local processing, machine
learning
algorithms may be implemented on a computer system remote from the user, for
example, on a
cloud computing network. This allows systems and methods disclosed here to
adapt as
additional data is collected over time Such algorithms may recognize a patient
repeating a body
motion to allow the algorithm to recognize a motion not accurately detected
the first time.
100601 Fig. 4 shows another example of motion detection by a device according
to an
embodiment of the disclosure. Here an able-bodied person executed a "3"-shaped
motion in
three repetitions. Again, IMUs provided gravity-corrected acceleration data
and the computer
calculated the time dependent trajectory of the person's limb. Again, as shown
by the position
graphs in the right-most column, the "3"-shape was found in each repetition.
Had a user
associated the -3"-shape and the -C"-shape motion with a different actions,
for example, a -key
grip" and a "cylindrical grasp," computer 20 could apply a different pattern
of neuromuscular
stimulation, resulting in hand motions to execute one or the other type of
grasping.
100611 According to another embodiment, training sets of motion data were
prepared for various
alphanumeric-shaped trajectories. First, the raw 3-axis gravity compensated
acceleration
obtained from the IMU was band-pass filtered (Butterworth, 8th order, 0.2 ¨
6Hz) and processed
offline for identifying training samples. The absolute value for the
acceleration along the 3-axis
was used to identify onset of movement by setting a threshold of 0.95g. The
movement onsets
were then used to segment the acceleration data over time along the X, Y, and
Z axis into
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windows ranging -0.1s to 0.9s with respect to onset. Each trial was visually
confirmed to be free
from any noisy artefacts or excessive jerk (derivative of acceleration) or if
it exceeded the is
window and such trials were excluded from further analysis. These training
sets were used to
train Dynamic Time Warping (DTW) and Long Short-Term Memory (LSTM) network
algorithms.
100621 The DTW algorithm optimally aligns a sample trajectory with respect to
a previously
determined template trajectory such that the Euclidean distance between the
two samples is
minimized. This is achieved by iteratively expanding or shrinking the time
axis until an optimal
match is obtained. For multivariate data such as acceleration, the algorithm
simultaneously
minimizes the distance along the different dimensions using dependent time
warping. According
to this embodiment, the algorithm was used to compute the optimal distance
between a test
sample and all the templates associated with the 2D and 3D trajectories. The
template with the
least optimal distance to the test sample, was selected as the classifier's
output. Since the
classifier's output is dependent on the quality of its templates, an internal
optimization loop was
used to select the best template trajectory from a set of training
trajectories. Within this loop, the
DTW scores of each training sample with every other training sample was
computed. Then the
training sample with the least aggregate DTW score, was chosen as the template
for that
trajectory, that is, the expected trajectory.
100631 In some embodiments, an LSTM network is used to analyze motion data.
According to
one such embodiment the LSTM network comprised of a single bidirectional layer
with 100 or
more hidden units provided with the MATLAB R2019b Deep Learning Toolbox.
Default values
were selected for most parameters. The LSTM network transformed the 2D or 3D
acceleration
data into inputs for a fully connected layer whose outcome was binary, i.e. 0
or 1. Next, a
softmax layer was used to determine the probability of multiple output
classes. Finally, the
network output mode was set at 'last', so as to generate a decision only after
the final time step
has passed. This allowed the LSTM classifier to behave similar to DTW and
classify trajectory
windows. During training of the LSTM network weights, adaptive moment
estimation (ADAM)
solver was used with a gradient threshold of 1 and maximum number of epochs of
200. Since all
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the training and validation data were 1 second long, zero padding was not
used. To implement
the LSTM network, a MATLAB R2019b Deep Learning Toolbox was used with default
values
for parameters other than the ones mentioned above.
100641 According to one embodiment, online classification of arm trajectories
was performed by
filtering and processing the raw acceleration signals in real-time using a
MATLAB script that
looped at 50Hz. Within the loop, the acceleration data was divided into 1-
second long segments
with 98% overlap. The DTW-based classifier was implemented and was designed to
compare the
incoming acceleration windows with 2D trajectories. If the optimal distance
between trajectories
were below 10 units (empirically determined), then positive classification was
issued, which then
triggered the NMES driver 14 to stimulate muscles to perform a complete
movement sequence of
opening and closing of the hand.
100651 According to one embodiment sensor data is input into a machine
learning algorithm that
is trained to identify particular motions as expected trajectories to
associate with actions. Such
training may be accomplished by using able-bodied persons or the unaffected
side (mirror image
of the movement) in a stroke patient. In a stroke patient, hemiplegia
(paralysis on one side of the
body) is very common. According to one embodiment, the stroke user uses their
unaffected side
to train the device's algorithms, or further tailor to, their movements. In
either case, the user
wears the device while performing natural reaching and various trajectories
under real-world
conditions with an additional sensor detecting hand opening and differing
grasping actions. Such
additional sensors include EMG (electromyogram) sensors placed over the
related muscles to
determine the hand grasping actions (open, close, key grip, cylindrical grip,
etc.). The amplitudes
of this EMG signal represent the muscle contraction strength, including its
duration and change
over time, and this data can be used directly to inform the electrical
stimulation amplitudes, and
their timing, applied by the NMES driver 14 to deliver a pattern of
stimulation signals to perform
the grasping action when a desired movement is recognized through
motion/trajectory
recognition algorithms. The device for detecting hand opening and differing
grasping actions
may also include a camera for recording images of such actions, an EMU, or
joint angle/bend or
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force sensor attached to the able-bodied hand used train the system to
determine the pattern of
stimulation signals.
100661 Additional sensors may also include a camera coupled with image
analysis and
positioned to capture the reaching trajectory and/or grasping motion as well
as bend/joint angle
and force sensors. Captured trajectory and grasping data is used to build a
database of pre-
trained trajectory or motion patterns to be associated with certain hand
actions. This data is used
to train a machine learning algorithm such as a deep learning neural network.
The device may be
trained (or partially trained) before the device is fitted to a disabled
person. Such training may
include the use of inputs to computer via input devices 24. For example, a
person training the
system to recognize a particular trajectory as an "S"-shaped path that
indicates a cylindrical-type
grasp may audibly say words such as "cylindrical grasp," "open," and "closed"
in synchrony
with the motion. The computer 20, using a microphone as input and known voice
recognition
techniques, reads the audio input and tags the sensor data. This tagged data
becomes part of the
training set of data for the machine learning algorithm. Alternatively,
motions used to train the
algorithm may be tagged using keystrokes on a keyboard, or computer 20 may be
equipped with
a camera that captures visual images of the user performing various tasks
(e.g., grasping objects
on a table, inserting pegs into a board) while recording motion data from IMUs
to associate
"natural" grasping motions with the associated hand motion.
100671 In another embodiment, a camera is located at the wrist (as part of a
band, sleeve / patch,
or clothing) to recognize objects as they are approached, thereby affecting
the stimulation
patterns to change the type of hand opening style (e.g. all fingers or just
thumb-index pinch
extensors activated) and when relative position of object to the hand slows
down/stops, then
flexors are automatically activated to initiate the grasp. Techniques for real-
time object
recognition using small portable devices using battery-powered microprocessors
(e.g., cell phone
technology) are well-known in the art. These techniques, combined with Al and
machine
learning methods such as support vector machines, convolutional neural
networks, and long
short-term memory (LSTM) recurrent neural networks for static and dynamic
image
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classification allow visual cues, such as the type of object being grasped, to
inform the system
how to position the patient's hand to coirectly and reliably grasp an object.
100681 When considering 2D and 3D motions (e.g. corkscrew movements in the
air), a large
variety of trajectories may be identified by the computer and associated with
various actions.
These trajectories can not only be used to drive neuromuscular stimulation to
restore movement,
but also can be used to drive prosthetic/robotic devices or mobility devices
like wheelchairs.
100691 A study was performed using a system according to the disclosure to
detect motion
trajectories corresponding to selected predefined trajectories. Two
participants with quadriplegia
were recruited for the study. Participant 1 was a 32 year-old male, injured 6
years prior, with a
C4/C5 ASIA (American Spinal Injury Association) B injury. He participated in
10 sessions, out
of which 7 sessions were used to record 2D and 3D arm movement trajectories.
During the
remaining 3 sessions, grasping intentions were decoded online (in real-time)
and used to drive a
custom neuromuscular stimulator with textile-based electrodes 12a, 12b, ...12n
housed in a
sleeve. This in turn allowed the participant to perform functional movements
(e.g. eat a granola
bar). Participant 2 was a 28 year-old male, injured 10 years prior, with a
C4/C5 ASIA A injury.
He participated in 3 sessions, which involved 2 training and 1 online testing
session.
100701 Participants were seated with their hands initially resting on a table.
A wireless sensor
module was attached to the wrist of their arm using a Velcro strap. The sensor
module included
a motion sensor 16a, 16b, ... 16n and an MCU is, as disclosed in previous
embodiments. While
both participants were bilaterally impaired, each still possessed residual
movement that allowed
reaching with at least one of their arms and was eventually used for the
study.
100711 During the study, verbal cues associated with different 2D and 3D
movement trajectories
were randomly called out to the participant. The participants were instructed
to perform the
reaching trajectories starting from the edge or corner of the table and move
towards the center,
using smooth movements that were up to a second long. Three different 3D
reaching trajectories:
a sideways arc, a vertical arc (e.g. reaching for a pen or marker lying on a
table), and a corkscrew
motion were trained. Additionally, four 2D trajectories (performed in the
horizontal plane)
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corresponding to well-known English and Greek letters: 5, E (epsilon or E), y
(gamma), and in
were trained. Experiments were conducted in blocks of 18-20 trials and
sufficient breaks were
given between blocks to minimize participant fatigue. Initially, the
participants were asked to
perform only and C trajectories because these were simple to learn and didn't
cause fatigue.
Later, once the participants became comfortable with moving their arm,
additional 2D and 3D
trajectories were added to the study. Thus, in the final datasets there was a
higher percentage of
2D trajectories (especially, S and E) than the remaining trajectories.
[0072] Over 250 training samples across 7 movement trajectories were recorded
for participant 1
and 96 samples from 5 movement trajectories were recorded for participant 2.
Trials with noisy
sensor data or incorrect labels were visually identified and removed from the
training set. A 5-
fold stratified cross-validation scheme was selected for evaluating DTW and
LSTM based
classifiers. Fig. 7 shows the mean standard deviation (SD) classification
accuracy for the 2
participants. Bar graphs compare classification accuracies (Mean SD) using
two methods:
DTW and LSTM. Performance was evaluated using both offline (2D & 3D) and
online (2D only)
arm trajectories. Statistical significance threshold was set at p < 0.05.
[0073] In the offline scenario both DTW and LSTM based classifiers performed
well for 2D
trajectories, achieving 94 + 5% and 98 + 3% accuracy, respectively. For
offline 3D trajectories
however, LSTM outperformed DTW and obtained 99 3% accuracy over 83 16%.
Using two-
sided Wilcoxon rank sum test, LSTM based classification accuracy was
significantly better than
DTW (p < 0.05) in both cases. Fig. 7 also shows the online performance of DTW
based classifier
for 2D trajectories. During online classification, a comparison is made
between 2 trajectories
(e.g. v/s E) or between a single trajectory and rest (e.g. in vls rest) and
achieved 79 5%
accuracy. To further evaluate each classifier's performance for type I and II
errors, cumulative
confusion matrices were calculated by adding the confusion matrices from each
fold for each
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participant. The resulting confusion matrices for both classifiers and for
both types of trajectories
are shown in Fig. 8.
100741 For DTW-based classifier, type I error occurred more frequently for 3D
than 2D
trajectories. The highest percentage of type 1 error occurred for the
corkscrew trajectory (37.8%),
followed by vertical arc (14%), (10.2%) and in (10%) trajectories. In terms
of type II errors,
DTW-based classifier misclassified vertical arc (14.5%), side arc (13.8%) and
S (8.33%)
trajectories as compared to rest of the classes. For LSTM-based classifier the
type I and II errors
were very low and ranged from 0 ¨ 3% for almost all trajectories, with the
exception in
trajectory that had a type I error rate of 40%. It is surmised that because
there were only 10 trials
of in trajectory for training, this sample set was too small for the LSTM
classifier to distinguish
this trajectory from other classes that had larger number of samples.
100751 As a further example, a system according to an embodiment of the
disclosure was tested
by a paralyzed person with residual shoulder and arm motion, but without
residual motion in his
hand. As shown in Fig. 6, the device recognized the natural reaching motion of
the person's arm
and shoulder and stimulated the persons thumb adduction and abduction muscles
to grasp a pen
standing in one cup. The person was able to lift the pen using residual arm
and shoulder motions
and transfer it to a second cup while the device continued to activate the
patient's muscles to
keep a grip.
100761 As another example, a system according to an embodiment of the
disclosure was tested
using an able-bodied person to predict muscle activation during a reaching and
grasping motion
based on training of an LSTM network using EMG signals. The subject was fitted
with EMG
sensors over the ring finger flexor and extensor muscles and an IMU 16a fitted
to the wrist.
Signals from the EMG and IMU were preprocessed with a microcontroller 18
implemented on a
circuit board, an ArduinoTM Nano 33 BLE. Data from the circuit board was
wirelessly
communicated to a computer 20 implementing an LSTM network, as described in
previous
embodiments. The subject performed repeated reaching and grasping motions
while data from
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the IMU and EMG were provided to the LSTM network. After training the LSTM,
the LSTM
was able to predict the timing and amplitude of muscle activity of the flexor
and extensor
muscles based on the trajectory of the subject's wrist.
100771 According to other embodiments, a device according to the disclosure
can be used to
enable movement of lower extremities. In one such embodiment, 'Mils are
affixed to a patient's
hips. 2D and 3D hip movements are detected by analyzing data from the IMUs.
Again, training
the algorithms can be achieved by outfitting an able-bodied person with TMUs,
cameras
observing limb position and motion, bend/joint angle sensors in the leg joints
and/or EMG
sensors on the muscles to be stimulated in a paralyzed person. Hip movements
can be used to
actuate muscles using NMES, for example, to correct the person's gait or
facilitate walking if
they are weak, paralyzed, or have drop foot. During normal walking, the left
hip/upper body
traverses a 2D "C" shaped curved trajectory in space before the right leg is
lifted. According to
one embodiment, this tell-tale signature trajectory is recognized and used to
trigger a muscle
stimulation pattern in the right leg to assist with the stepping sequence.
NMES electrodes may be
placed over any muscle activating the joint of interest. For example, where a
device according to
the disclosure is used to facilitate rehabilitation following knee surgery,
actuators may be placed
over the quadricep, hamstring, calf, and foot extensor muscles to stimulate
the muscles to
encourage the wearer to perform an improved walking gait. Stimulation may be
combined with
the person using their arms to partially support their weight on a walker or
parallel bars to assist
their hip/upper body movement. The trajectory of the right hip is then
detected and used to
stimulate muscles of the left leg.
100781 Systems according to embodiments of the disclosure may be integrated
with gloves,
shoes, and other garments that include force sensors. Such sensors detect
contact and pressure
applied between the wearer's hand and a grasped object or monitor the
placement of the foot
while stepping. Such garments may also include bend/angle sensors at the
elbow, wrist, knee,
ankle, or other joint to provide trajectory, orientation, and motion
information to the system
and/or data related to intention (during machine learning algorithm training
in able-body users)
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100791 According to another embodiment of the disclosure, information about
the trajectory,
orientation, and position of the patient's limbs is collected by the system
andrecorded. Such
information is used to track body part trajectories and/or joint movements (or
ranges of motion)
during physical therapy. Systems according to the disclosure provide a low-
cost way for medical
professionals to track progress and characterize motion (like gross arm
movement in space) in
rehabilitating a stroke or spinal cord injury patient. Such systems are less
expensive and less
cumbersome than current methods of monitoring limb position and motion that
rely on expensive
robotic systems or table sized devices. In addition, machine learning
algorithms can compare a
patient's movements with movements by able-bodied volunteers and other
patients at various
stages of recovery and grade or classify the patient's movements. This
information may allow
professionals to optimize therapies, provide patients with better feedback,
and indicate progress
of patient during their recovery.
100801 During the training of user-specific (custom) trajectories, voice
recognition, a brain-
computer interface (BCI) ¨ non-invasive or invasive (EEG), a touch pad, and/or
able-bodied
hand/leg motion can be used to initiate the training or select the desired
action or hand or foot
movement to be associated with the trained trajectory. Furthermore, pre-
trained trajectory
profiles can be stored in the device/system so that no training will be
required. For example,
letters, numbers, and patterns that are already known by the user can be
available and
automatically recognized without user-specific training.
100811 According to another embodiment, instead of, or in addition to
stimulating muscles to
perform an action in response to a recognized trajectory, the system can also
apply therapeutic
stimulation elsewhere in the patient's neurological system. According to a
still further
embodiment, one or more of electrodes 12a, 12b, 12c ...12n are adapted to
apply a stimulation
current to the patient's peripheral nerves or to the patient's central nervous
system (CNS) for a
wide variety of applications including movement/sensory recovery and chronic
pain. It is well
known that ncurostimulation can also be effective in treating pain through
implanted and
transcutaneous stimulation devices. It is also well known that certain types
of movements
(raising the arm or bending over at the waist) can cause pain. According to
some embodiments of
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the disclosure, translational and/or rotational motion of a body part that
might cause pain triggers
stimulation to reduce pain caused by the detected motion.
100821 Using motion/trajectory recognition to trigger various types of
stimulators according to
embodiments of the disclosure can have many benefits. For example, vagus nerve
stimulation
has been shown to improve the efficacy of upper limb rehabilitation. According
to one
embodiment, the system triggers vagus nerve stimulation cervically (neck) or
auricularly (ear)
during movement rehabilitation for stroke, SCI, traumatic brain injury, MS,
etc. Such
therapeutic stimulation can be applied to other nerves, such as the trigeminal
nerve and other
cranial nerves or peripheral nerves feeding muscles of interest. Systems
according to the
disclosure can also be used to trigger, control, and and/or modulate various
forms of brain
stimulation including TMS (transmagnetic stimulation) and tDCS (transcutaneous
direct-current
stimulation), tACS (transcutaneous alternating current stimulation), TENS
(transcutaneous
electrical nerve stimulation), or spinal cord stimulation (which sends signs
down the spinal cord
and up to the brain) to promote neuroplasticity, recovery after stroke or
traumatic brain injury,
and/or reduce pain.
100831 The signals from the brain in spinal cord injury patients are sometimes
blocked or
attenuated berme leaching the muscles due to the damaged spinal cord.
Stimulation over or near
the damaged spinal cord pathways raises excitability in those pathways and may
facilitate
movement and rehabilitation in spinal cord injury patients. Known systems for
applying spinal
cord stimulation are typically controlled manually through a control pad or
device, not by the
patient's body motions. According to an embodiment of the disclosure, one or
more electrodes
12a, 12b, 12c, ... 12n are positioned epidurally or preferably
transcutaneously over the patient's
spinal cord. The system senses particular trajectories made by the patient
during physical
therapy and, in addition to applying NMES stimulation to cause muscles to
execute a desired
motion of a disabled limb, the system triggers transcutaneous spinal cord
stimulation, to boost
neural signals (by raising excitability of inter-neurons) that have been
diminished as a result of
spinal cord injury. Likewise, one or more electrodes 12a, 12,b, 12c, ... 12n
may be positioned
above, over, or below a spinal cord injury site to apply stimulation to the
cord injury and/or
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pathways above and/or below the injury, which may assist healing of neurons
impaired by the
injury and/or strengthening neuronal connections. By coupling a patient's
volitional motion with
such stimulation, the patient can control their own stimulation patterns
potentially further
promoting neuroplasticity and movement and/or sensory function recovery.
100841 For patients who have suffered a stroke, electrical or transmagnetic
stimulation over or
near the site of the injury in the brain or brain stem may assist in healing
of damaged neurons.
According to a further embodiment of the disclosure, one or more electrodes on
the scalp or a
magnetic coil over the scalp are positioned. Stimulation signals are applied
to these electrodes or
coil in response to a detected motion trajectory, instead of, or preferably in
addition to NMES
signals that cause the patient's disabled limb or appendage to move. Such
brain stimulation,
coupled with the patient's intention to move a disabled limb or appendage, may
help restore
some of the function of motor neurons injured by the stroke.
100851 Because systems according to the disclosure are relatively inexpensive,
portable, and can
be controlled by the patient alone, without the help of a therapist or other
professional, a patient
can be equipped with a device (wearable sleeve(s), patch(es), etc.) they can
take home,
increasing the hours per week available for rehabilitation.
100861 Fig. 9 shows another embodiment of the disclosure. A prosthetic hand
100 is fitted to the
arm of a person that has suffered a transradial amputation. The prosthetic
hand 100 includes a
sensor housing 10. Sensor housing 10 may include sensors 16a, 16b, ... 16n as
discussed above
to detect acceleration, velocity, position, and rotation of the wearer's arm.
Controller 21
integrating the functions of the MCU 18 and computer 20 discussed in the
previous embodiments
is connected with the senor array and receives signals indicating motion
trajectories executed by
the wearer using able-bodied joints, for example, the shoulder, torso, and
upper arm. As in the
previously described embodiments, controller 21 determines whether the wearer
has executed a
motion that corresponds with an intended activation of the hand. Controller 21
is connected with
actuators 112a, 112b, ... 112n. These actuators drive motions of the fingers
or the prosthesis
100. As with previous embodiments, one or more predetermined trajectories are
associated with
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particular motions of the hand. For example, when the wearer moves his or her
upper arm,
shoulder, and torso to move the prosthesis in a "rainbow arc," which as
discussed above might
indicate the intention to perform a pinch grasp, actuators 112a, 112b, ...112n
are energized to
move the fingers to execute the intended grasping motion.
[0087] The embodiment shown in Fig. 9 is for a prosthetic hand 100. The
disclosure is not
limited to a hand prosthesis. Other types of prostheses can be controlled
using a device
according to the disclosure. For example, a foot prosthesis could be provided
that senses the
walking motion of a wearer's leg and operates actuators to orient the foot in
synchrony with the
wearer's gait.
[0088] According to another embodiment, systems according to the disclosure
can assist in the
training or physical therapy of otherwise able-bodied persons to provide
active resistance during
exercise. Motion/trajectory recognition of various limbs is used to stimulate
non-paralyzed
muscles for sports training or physical therapy. For example, the rotation
velocity and linear
acceleration of a person's forearm is detected using IMU and/or gyroscopic
data from sensors
mounted on the forearm as part of a sleeve, patch, or other attachment. This
motion is normally
caused by the bicep. In response to the detected motion, the system triggers
antagonist muscles
including the triceps to provide active resistance to the bicep, proportional
to the forearm's
measured rotational velocity. According to one embodiment, the proportionality
factor is a
settable parameter that allows the user to vary the resistance.
[0089] While illustrative embodiments of the disclosure have been described
and illustrated
above, it should be understood that these are exemplary of the disclosure and
are not to be
considered as limiting. Additions, deletions, substitutions, and other
modifications can be made
without departing from the spirit or scope of the disclosure Accordingly, the
disclosure is not to
be considered as limited by the foregoing description.
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Representative Drawing
A single figure which represents the drawing illustrating the invention.
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(86) PCT Filing Date 2021-03-05
(87) PCT Publication Date 2021-09-10
(85) National Entry 2022-09-01

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National Entry Request 2022-09-01 2 53
Declaration of Entitlement 2022-09-01 1 13
Patent Cooperation Treaty (PCT) 2022-09-01 1 56
Patent Cooperation Treaty (PCT) 2022-09-01 2 65
Description 2022-09-01 33 1,659
Claims 2022-09-01 6 175
Drawings 2022-09-01 9 220
International Search Report 2022-09-01 1 48
Patent Cooperation Treaty (PCT) 2022-09-01 1 37
Correspondence 2022-09-01 2 54
Abstract 2022-09-01 1 18
National Entry Request 2022-09-01 8 233
Representative Drawing 2022-12-15 1 8
Cover Page 2022-12-15 1 48
Representative Drawing 2022-11-08 1 18
Amendment 2023-03-28 7 206
Description 2023-03-28 33 1,706